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Enodar, the Industry s First GCRO, Brings Genomics Expertise to Clinical Trials


As a biostatistician at the Fred Hutchinson Cancer Research Center, Lue Ping Zhao recognized that most genomics analysis methods were adequate for drug discovery, but exposed a surprising lack of foresight: They were missing the rigorous statistical foundation necessary for the downstream stages of drug development, particularly those needed to meet the FDA’s requirements for clinical trials.

In early 2001, with the commercial bioinformatics sector still in bloom, Zhao launched Enodar Biologic to fill this perceived gap in the marketplace. The company planned to sell a statistical microarray analysis suite called GenePlus that Zhao and his colleagues
had developed at the Hutch. Predictably, however, “through the last two and a half years of our exploration of the market, we soon recognized that what people actually need is more solutions than actual tools,” Zhao explained.

Grim market conditions — accompanied by a raft of bioinformatics software offerings from statistics heavy-hitters like SAS, Insightful, and SPSS — led to the realization “that we really needed to move more toward providing solutions as a GCRO — a genomics contract research organization.” Although Enodar is still developing and selling its own software tools, “we don’t really care if the tools are from us or from someone else,” Zhao said.“We are integrating the best solutions we can find.”

The company, which boasts an “extended team” of 25 employees, is hoping to serve as a CRO for pharmaceutical companies looking to incorporate genomics data into their clinical trials — a still-nascent area that the company believes is poised to boom. The FDA is still formulating its guidance for integrating microarray and other genomic data into the clinical trial process, and Zhao is acting as a consultant for the agency as it weighs its options, he said.

Statistical analysis is quickly gaining importance as researchers seek better methods to determine what results are reproducible and which are not, Zhao said. “For example, what is the true discovery rate, but at the same time, what is the false discovery rate? You need to know both sides of that so that when you look at a list of genes or compounds or evidence, you know exactly where they stand. That kind of evidence is lacking at this moment, but that will be very important for FDA evaluations,” he said.

Added COO Rob Arnold: “The majority of companies are really in the discovery phase, and at some point they’re going to move from discovery to production orientation. Yet if you’re going to build a milestone-based framework to get your products out into the marketplace and get FDA approval for your compound or your diagnostic, statistics are integral to making that happen.”

Enodar is hoping to see its statistics-based technology framework — or at least its services — supported by the FDA and other regulatory agencies. “They know the wave is coming, they know they have to update their methodologies and so forth, and what we see is the ability to be a participant in that process,” Arnold said.

In the meantime, Enodar is bringing in revenues through consulting projects and government grants. Most recently, it signed a contract to build a translational state array analysis database system for the biochemistry department at the University of Washington.

The web-based database system, which will be available to researchers at the university as well as to the general public, will allow users to analyze the role of translation in regulating progression of cells through the cell cycle. It is slated for completion in March of 2004.

This week, the company will announce its latest government grant — a Phase I Small Business Innovation Research award from the NIH for the development of SNP detection software. The technology will build on a gene expression software system called GeneClinic developed under an SBIR grant awarded last July.

“We would like to grow with revenue from the large pharmaceutical companies rather than from government, but at the same time government funding does allow us to continue our R&D effort,” said Zhao.

“We expect over time that the bulk of our revenues will come from client engagements,” Arnold added.

— BT

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